Currently, there are a number of therapeutic agents for which intranasal delivery would be desirable but which do not have the appropriate solubility. These agents are therefore often delivered intravenously or rectally. However, intravenous administration requires skilled labor and hospitalization, which are time consuming processes that often cause delay in the treatment, while rectal administration often has poor patient compliance. For other agents, intranasal delivery is possible but only when combined with organic excipients, which may cause irritation and slow absorption. Examples of such therapeutic agents include certain benzodiazepines. Currently, intravenous (i.v.) benzodiazepines such as diazepam (DZP), lorazepam, or midazolam (MDZ) are the first choice drugs for the treatment of status epilepticus (SE), acute repetitive seizures (ARS) and other neurological emergencies. Rectal DZP is effective for ARS, but both patients and caregivers object to this route of administration, resulting in poor patient compliance. Soon to be marketed intranasal formulations also exist, but these formulations are based on organic excipients.
Thus, there is a need for new intranasal formulations of therapeutic agents, e.g., new formulations of benzodiazepines, as well as new compounds and formulations for the treatment of diseases or disorders, such as SE.